aScreen - Otoacoustic emission system, battery-powered - ARTG 435151
Access comprehensive regulatory information for aScreen - Otoacoustic emission system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 435151 and sponsored by AIMedical International Pty Ltd, manufactured by Neurosoft LLC in Russia. The device registration started on January 18, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The aScreen system is intended for hearing screening in patients of all ages including newborns. The aScreen system can be used in healthcare and hearing diagnostic centres, maternity centres, ambulatory-care and testing laboratories of research institutes. The aScreen system is to be used by trained personnel only, such as audiologists, ear-nose-throat (ENT) doctors, paediatricians, and other hearing health care professionals and audiologically trained technicians. The system should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.